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Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

Health Highlights: Aug. 21, 2018

Posted today in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Wildfire Smoke Causing Poor Air Quality in U.S. Pacific Northwest Smoke from wildfires will cause poor air quality in parts of the U.S. Pacific Northwest this week, officials warn. Air quality alerts are in effect for much of Washington state through Wednesday, according to the National Weather Service, the... Read more

Pennsylvania Case Could Affect Evidence for Malpractice Defense

Posted today in News for Health Professionals

TUESDAY, Aug. 21, 2018 -- The Pennsylvania Supreme Court has agreed to hear a case that could affect what evidence physicians may present in defense during medical malpractice suits, according to an article published in the American Medical Association's AMA Wire. The appeals to the case, Mitchell v. Shikora et al., center on the question of whether evidence concerning the known risks and complications of a surgical... Read more

Hypnosis Doesn't Cut Post-Op Pain in Breast Cancer Surgery

Posted today in News for Health Professionals

TUESDAY, Aug. 21, 2018 -- Hypnosis before general anesthesia does not reduce postoperative breast pain among patients undergoing minor breast cancer surgery, according to a study published online Aug. 17 in JAMA Network Open. Jibba Amraoui, M.D., from the University of Montpellier in France, and colleagues conducted a randomized trial involving 150 women scheduled for minor breast cancer surgery. Participants were... Read more

Large Number of Presumed Sudden Cardiac Deaths Are Not

Posted today in News for Health Professionals

TUESDAY, Aug. 21, 2018 -- A large percentage of deaths attributed to cardiac arrest are neither sudden nor unexpected, according to a study published recently in Circulation. Zian H. Tseng, M.D., from the University of California in San Francisco, and colleagues identified all incident deaths attributed to out-of-hospital cardiac arrest (patients between 18 and 90 years of age in San Francisco County) based on... Read more

Side Effects of Biologics for Rheumatic Dz May Up Anxiety

Posted today in News for Health Professionals

TUESDAY, Aug. 21, 2018 -- Potential side effects of biological agents may increase anxiety in patients with rheumatic disease, according to research published in the June issue of the International Journal of Rheumatic Diseases. Yavuz Pehlivan, M.D., of Uludag University in Bursa, Turkey, and colleagues enrolled 1,134 patients with a diagnosis of rheumatic disease who used biological agents for at least three... Read more

Sentinel Lymph Node Mapping Most Cost-Effective for Uterine CA

Posted today in News for Health Professionals

TUESDAY, Aug. 21, 2018 -- Sentinel lymph node mapping has the lowest costs and highest quality-adjusted survival compared to both routine and selective lymphadenectomy for managing low-risk endometrial carcinoma, according to a study published in the July issue of Obstetrics & Gynecology. Rudy S. Suidan, M.D., from the University of Texas MD Anderson Cancer Center in Houston, and colleagues evaluated the... Read more

HPV Test May Replace Pap for Some Women, New Guidelines Say

Posted today in Medical

TUESDAY, Aug. 21, 2018 -- The Pap smear has long been the gold standard for cervical cancer screening, but an expert panel now says the HPV (human papillomavirus) test is also an option for women over 30. These women now have three choices under new recommendations issued by the U.S. Preventive Services Task Force (USPSTF): A Pap test screening every three years. An HPV test alone every five years -- HPV is a virus... Read more

New Lab Test Spots Heart Attack, Risk of Future Heart Woes

Posted today in Medical

TUESDAY, Aug. 21, 2018 -- A new method of diagnosing heart attack patients in the emergency department is more accurate and faster than current methods, researchers say. The laboratory score can also identify patients at risk of more heart problems after they leave the hospital, according to the study published Aug. 20 in the CMAJ (Canadian Medical Association Journal). "This lab score may reduce both the number of... Read more

Kids' Play Is Healthy, Pediatricians' Group Says

Posted today in Medical

TUESDAY, Aug. 21, 2018 -- Play is a child's most important work, preschool teachers like to say, and a new American Academy of Pediatrics report wholeheartedly agrees. Play is a crucial way for kids to develop social and mental skills, head off stress and build a healthy bond with parents, the child health experts say. "We're recommending that doctors write a prescription for play, because it's so important," said... Read more

Gut Enzyme Could Help Solve U.S. Blood Shortages

Posted today in Medical

TUESDAY, Aug. 21, 2018 -- An enzyme found in gut bacteria could convert type A blood into universal type O blood, a scientific feat that would significantly boost blood supplies, a new study suggests. This enzyme converts A blood into O blood approximately 30 times faster than any enzyme on record, and it appears to do it in a safe and effective manner, said lead researcher Stephen Withers, a professor of... Read more

FDA Approves New Eylea (aflibercept) Injection Dosing Schedule in Wet Age-Related Macular Degeneration

Posted 4 days ago in New Drug Approvals

TARRYTOWN, N.Y., Aug. 17, 2018 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ : REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Eylea (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD). The sBLA was based on second-year data from the Phase 3 VIEW 1 and 2 trials in which patients... Read more

FDA Approves Opdivo (nivolumab) for Certain Patients with Previously Treated Small Cell Lung Cancer

Posted 4 days ago in New Drug Approvals

PRINCETON, N.J.--(BUSINESS WIRE)--August 17, 2018 -- Bristol-Myers Squibb Company (NYSE:BMY) today announced that Opdivo (nivolumab) received approval from the U.S. Food and Drug Administration (FDA) as the first and only Immuno-Oncology treatment option for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy.1... Read more

Sun Pharma Announces FDA Approval of Cequa (cyclosporine) Ophthalmic Solution to Treat Dry Eye Disease

Posted 4 days ago in New Drug Approvals

MUMBAI, India & PRINCETON, N.J.--(BUSINESS WIRE)-- August 16, 2018 -- Sun Pharmaceutical Industries Ltd. (Reuters:SUN.BO, Bloomberg:SUNP IN, NSE:SUNPHARMA, BSE:524715, “Sun Pharma” and includes its subsidiaries and/or associate companies) today announced that Sun Pharma has received approval for Cequa (cyclosporine ophthalmic solution) 0.09%, from the U.S. Food and Drug Administration (FDA). Cequa is indicated to... Read more

FDA Approves Lenvima (lenvatinib) for First-line Treatment of Unresectable Hepatocellular Carcinoma (HCC)

Posted 4 days ago in New Drug Approvals

Woodcliff Lake, NJ and Kenilworth, NJ, Aug. 16, 2018 – Eisai Inc. and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) approved the kinase inhibitor Lenvima (lenvatinib) for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). This approval was based on results from REFLECT (Study 304), where L... Read more

Evoke Pharma’s Gimoti NDA Accepted for FDA Review

Posted 5 days ago in New Drug Applications

SOLANA BEACH, Calif., Aug. 16, 2018 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that the Company’s 505(b)(2) New Drug Application (NDA) for Gimoti™, the Company’s nasal spray product candidate for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis, has been accep... Read more

FDA Approves Kalydeco (ivacaftor) for Cystic Fibrosis in Children Ages 12 to <24 Months with Certain Mutations in the CFTR Gene

Posted 6 days ago in New Drug Approvals

BOSTON--(BUSINESS WIRE)--Aug. 15, 2018-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) approved Kalydeco (ivacaftor) to include use in children with cystic fibrosis (CF) ages 12 to &lt;24 months who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to Kalydeco based on clinical and/or... Read more

Motif Bio Announces FDA Acceptance of New Drug Application With Priority Review for Iclaprim for Treatment of Acute Bacterial Skin and Skin Structure Infections

Posted 7 days ago in New Drug Applications

NEW YORK, Aug. 14, 2018 (GLOBE NEWSWIRE) -- Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, today announced that the U.S. Food &amp; Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for iclaprim, a targeted, Gram-positive investigational antibiotic, for the treatment of acute bacterial skin and skin structure... Read more

FDA Accepts New Drug Application (NDA) to Review Midazolam Nasal Spray, an Investigational Product for the Acute Treatment of Seizure Clusters

Posted 8 days ago in New Drug Applications

Brussels (Belgium) &amp; Atlanta Georgia, August 13th 07:00 (CEST): UCB today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for midazolam nasal spray*, an investigational product for the acute treatment of seizures in patients who require control of intermittent bouts of increased seizure activity (e.g. seizure clusters, acute repetitive... Read more

FDA Advisory Committee Recommends Approval of Paratek’s Omadacycline

Posted 13 days ago in New Drug Applications

BOSTON, Aug. 08, 2018 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ: PRTK) today announced that the Antimicrobials Drug Advisory Committee of the U.S. Food and Drug Administration voted in favor of the approval of intravenous (IV) and oral omadacycline for the treatment of acute bacterial skin and skin structure infections (ABSSSI) (17-1) and community-acquired bacterial pneumonia (CABP) (14-4). ... Read more

Complete Response Letter Issued for Remoxy

Posted 2 weeks ago in New Drug Applications

AUSTIN, Texas, Aug. 06, 2018 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq: PTIE) today announced it had received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Remoxy, an abuse-deterrent, extended-release form of oxycodone. According to FDA, “The data submitted in [the] NDA do not support the conclusion that the benefits of [Remoxy] E... Read more

World Health Organization Recommends the Use of Bedaquiline in all Conventional Multidrug-Resistant Tuberculosis Treatment Regimens

Posted 4 days ago in Clinical Trials

Beerse, Belgium, August 17, 2018 – Johnson &amp; Johnson today acknowledges the issuance of a “Rapid Communication” by the World Health Organization (WHO) describing key changes to treatment guidelines for multidrug- and rifampicin-resistant tuberculosis (MDR/RR-TB). The document describes a regrouping and ranking of MDR-TB drugs based on the latest evidence about the balance of effectiveness to safety. The oral medi... Read more

Teva and Regeneron Announce Positive Topline Phase 3 Fasinumab Results in Patients with Chronic Pain from Osteoarthritis of the Knee or Hip

Posted 4 days ago in Clinical Trials

JERUSALEM &amp; TARRYTOWN, N.Y.--(BUSINESS WIRE)--Aug. 16, 2018-- Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive topline results from a Phase 3, randomized, double-blind, placebo-controlled study of fasinumab in patients with chronic pain from osteoarthritis (OA) of the knee or hip. At the week 16 primary efficacy analysis, the... Read more

Janssen Reports Positive Topline Results for ATLAS Phase III Study of a Novel, Long Acting Injectable Two-Drug Regimen for the treatment of HIV-1

Posted 5 days ago in Clinical Trials

CORK, IRELAND, August 15, 2018 – The Janssen Pharmaceutical Companies of Johnson &amp; Johnson today confirmed positive topline results from the global, Phase III Antiretroviral Therapy as Long-Acting Suppression (ATLAS) study of the first investigational long-acting injectable two-drug regimen (2DR) for the treatment of HIV-1. The ATLAS study results showed long-acting rilpivirine (Janssen Sciences Ireland UC) a... Read more

Gemphire Announces Termination of Phase 2a Clinical Trial of Gemcabene in Pediatric NAFLD

Posted 11 days ago in Clinical Trials

LIVONIA, Mich., Aug. 10, 2018 (GLOBE NEWSWIRE) -- Gemphire Therapeutics Inc. (NASDAQ: GEMP), a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for cardiometabolic disorders, including dyslipidemia and nonalcoholic steatohepatitis (NASH), announces today that the Data and Safety Monitoring Board (DSMB) at Emory University School of Medicine overseeing the investigator-led... Read more

Orphazyme Announces Enrollment of First Patient in Phase III Clinical Trial of Arimoclomol for ALS

Posted 11 days ago in Clinical Trials

Copenhagen, August 10, 2018 – Orphazyme A/S, a biopharmaceutical company dedicated to developing treatments for patients living with rare diseases, today announced that the first patient has received the first dose in its Phase III clinical trial of arimoclomol for Amyotrophic Lateral Sclerosis (ALS). Thomas Blaettler, Chief Medical Officer, said: “The enrollment of the first patient in our Phase III trial for ALS... Read more